A clinical trial to study the effect of a combination therapy (oral ketamine and escitalopram) and escitalopram alone in elderly patient with depression, when given early in the course of treatment.

Phase 4

Conditions: Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic featuresHealth Condition 2: F331- Major depressive disorder, recurrent, moderateHealth Condition 3: F321- Major depressive disorder, singleepisode, moderateHealth Condition 4: F322- Major depressive disorder, singleepisode, severe without psychotic features

Registration Number: CTRI/2023/04/051777

Lead Sponsor: King George Medical University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Patient and Caregiver both giving valid informed consent.

A patient diagnosed with the first episode or recurrent episodes of depressive disorder, moderate or severe (F32.1, F32.2, F33.1, F33.2 with or without F34.1 as per ICD 10).

Hamilton Rating Scale for Depression (HAMD 17) score of at least 14 or above and on the Geriatric Depression Scale (GDS -30 ) score of at least 20 or above.

Drug-free patient in the current episode - >No previous therapeutic exposure to any anti-depressant in the current episode.

Free of antidepressant use in last two weeks (Patients with previous antidepressant treatment); For fluoxetine, the patient should be free from the drug over the last six weeks.

Exclusion Criteria

Presence of any psychotic symptoms in the current episode or other co-morbid psychiatric disorders (excluding personality disorders).

Current history of substance abuse, harmful use, and dependence (except for Tobacco).

Presence of any Neurological disorder like Parkinsonâ??s disease, Cerebrovascular stroke, or dementia of any type.

History of intracranial mass, intracranial hemorrhage, Cerebral trauma/ traumatic brain injury.

Uncontrolled Hypertension, uncontrolled Diabetes, or any medical illness requiring immediate intervention.

Patient on thyroxin or any other disorder involving the endocrine system.

Current medical history of severe renal or hepatic insufficiency.

Vitamin B12 deficiency or raised homocysteine level as evident on recent (within four weeks) serum levels.

Any contraindications for ketamine or an antidepressant being used (e.g; hyponatremia )( For ketamine: Acute Porphyrias, severe cardiac disease, uncontrolled hypertension, history of head trauma, history of stroke) [22]

Any previous reaction to ketamine ( as reported by the participant)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DECREASE IN SEVERITY OF DEPRESSIVE SYMPTOMS ( DECREASE IN HAM D scores) <br/ ><br>Side effects reportedTimepoint: DAY 0 <br/ ><br>DAY 1-7 <br/ ><br>DAY 7 <br/ ><br>DAY 14 <br/ ><br>DAY 42

Secondary Outcome Measures